UA67813C2 - Pressure-compensating device in dual container - Google Patents

Abstract

Dual containers, consisting of an inner container (2) and a diffusion-tight outer container (1) are used for medical fluids. The inner container collapses when the fluid is removed. A pressure-compensating device is required to compensate the pressure between the gas chamber (15) that is located between the inner and outer container and the surrounding area of the dual container, whereby the loss of fluid is kept to a minimum by diffusion from the collapsible inner container. At least one duct (7) that links the gas-filled space to the surrounding area of the dual container is used for this purpose. The time constant for compensation of a pressure differential of several millibars is several hours. This is achieved by selecting the length of the duct and cross section thereof. The at least one duct can be produced individually or a plurality of ducts can be provided in the form of pores in an open-pored sintered material or a permeable membrane. The pressure-compensating device enables the dual container to be stored for years and, if the fluid is removed in portions in a correct manner, it can be used for several weeks. During these periods, the amount of liquid in the inner container or the concentration thereof varies substantially less than if a dual container known per se is used.

Description

Description of the invention

The present invention relates to a device for equalizing pressure in a two-chamber vessel (ie, a vessel with 2 double walls), consisting of a hard non-deformable outer vessel and a soft deformable inner vessel. At the same time, the inner vessel is filled with liquid.

The basis of this invention was the task of developing a device suitable for equalizing the pressure between the surrounding air environment (i.e., atmospheric pressure) and the gas-filled intermediate space located between the inner and outer vessels (gas intermediate space), while 70 such a device should be economical in manufacturing and protected against clogging.

Liquids containing, for example, a certain medical preparation, are stored, as is known, until their use in a soft (flexible) inner vessel located in a hard non-deformable outer vessel. When liquid is taken from the inner vessel by the dosing pump, the inner vessel is compressed. In the absence of an opening in the outer vessel, a rarefaction is formed in the closed intermediate space between both of these vessels. 79 When using a dosing pump capable of creating only a small suction pressure, liquid selection becomes difficult immediately, as soon as the vacuum between these two vessels is approximately equal to the suction pressure. In this case, equalization of pressure in the intermediate space between both specified vessels should be ensured.

OPE 4139555 describes a vessel consisting of a solid outer vessel and an easily deformable inner package. This vessel is made by joint extrusion blow molding from two thermoplastics that do not form bonds between themselves. The outer vessel has a closed bottom and is equipped with at least one opening to equalize the pressure between the environment and the space between the outer vessel and the inner package. At that part of the outer vessel, where its wall is stepped, correspondingly, with a ledge, into the neck, there is at least one non-welded seam between two non-welded sections of the wall of the outer vessel located opposite each other. At the same time, it is desirable to provide two non-welded seams on the indicated stepped area of the outer vessel (Ge). The inner package is hermetically sealed in this area with welded seams. Air can enter the space between the outer vessel and the inner package through unwelded seams located on the stepped part of the outer vessel. At the same time, the non-welded edges adjacent to the open seam on the stepped section of the outer vessel show a tendency to close the She when discharging. Therefore, in the upper part of the wall of the outer vessel, it is additionally desirable to provide several "-holes as ventilation, obtained, for example, with the help of ultrasound or mechanical processing by perforating the outer vessel. All openings in the wall of the outer vessel on the stepped area and in the upper part of the wall are closed by the casing of the pump mounted on the vessel. uh-

Known two-chamber vessels have open seams or holes in the outer vessel. At the same time, the outer vessel is always made of thermoplastic. at

If the internal vessel does not have absolute diffusion impermeability, and the liquid that fills this internal vessel is volatile or contains volatile components, then such a liquid gradually "leaks" from the internal vessel as a result of diffusion or, under certain conditions, an unacceptable change in the composition of this liquid is observed . "

The specified effect is additionally enhanced in the case when, after pressure equalization, no air enters the space between the outer vessel and the inner vessel for a long time, and the holes provided for pressure equalization in the outer vessel have the same cross-section as the cross-section of the holes with » known two-chambered vessels.

Based on the above, the present invention was based on the task of developing a device for a two-chamber vessel, which would be suitable for equalizing the pressure between the atmospheric air and the gas space located between the inner vessel and the outer vessel, even in the case when the inner vessel is filled with air or with the content of a volatile component liquid, in relation to which this inner vessel has limited diffusion impermeability. At the same time, even with long-term storage of a complete two-chamber vessel and with its many-month use in accordance with the intended purpose, the amount of liquid in the inner vessel or the concentration of liquid components should change only within significantly smaller limits than - 20 when using known two-chamber vessels.

This task is solved according to the invention by means of a device for equalizing the pressure in a two-chamber vessel consisting of an outer vessel and an inner vessel. At the same time, the inner vessel is filled at least partially with a volatile liquid. This two-chamber vessel itself is contained in a gas-filled surrounding space. The proposed device for pressure equalization is characterized by the presence of the following features:

GF) the inner vessel is made partially diffusion-impermeable to the indicated at least partially volatile liquid and is made soft (deformed), and the outer vessel is made diffusion-impermeable and rigid (undeformed), the outer vessel is hermetically connected to the inner vessel, 60 between both of these vessels are a gas space, the specified gas space between the outer and inner vessels is connected by at least one channel to the space around the two-chamber vessel, the cross-sectional area of this at least one channel corresponds to the equivalent diameter from 10 to 500μm and because the length of the specified at least one channel is from five thousand times to one-tenth of its equivalent diameter.

The equivalent diameter of at least one channel means the diameter of a circle whose area is equal to the cross-sectional area of this at least one channel. The length of at least one channel specified

It is optimally from one hundred times to one tenth, most optimally from ten times to one times the value of its equivalent diameter.

It is desirable that the length of the geometric figure, the shape of which the channel has in the cross section, is approximately equal to its height, that is, the cross section is optimally round, close to square or triangular in shape. In addition, the channel can have a rectangular, trapezoidal, semicircular, slit-like or irregular shape in cross-section. The ratio of the lengths of the sides in the slot-shaped channel can be up to 50:1. In addition, several channels can be arranged in an orderly manner, for example, at the nodal points of some grid, or in an unordered manner, for example, with a statistical distribution. Is the cross-sectional area of the channel less than 1 mm? and can reach several thousand square micrometers.

The channel can be straight or curved or have the form of a meander, spiral or helical line. The channel, optimally 75 in the form of an opening, can be made in the wall of the outer vessel. In addition, the channel can be made in an insert, preferably made of plastic, which is hermetically placed in the wall of the outer vessel, optimally in a recess sunk inside this outer vessel in its bottom. In this case, the end of the channel facing the intermediate space is connected to the hole in the wall of the outer vessel. The cross-section of this opening is larger than that of the channel. 20 At one end of the channel, ideally at the end facing the surrounding space, a gas-permeable filter, for example an element made of non-woven material of sintered material with open pores, can be installed as protection against dust.

The end of the channel facing the surrounding space during storage of a two-chamber vessel filled with liquid can be sealed with a heat-welded film, which is completely or partially torn off or punctured before the first sampling of liquid from c 25 of the inner vessel.

The walls of at least one channel can be smooth or rough. and)

The specified at least one channel can be made in the form of a microhole, which is pierced, for example, by a laser beam in a plate. A meander-shaped or spiral channel can be obtained by selective etching of the silicon surface, while such a channel can have a triangular or trapezoidal cross-section. In addition, the channel "Z 30" having a triangular cross-section and almost any shape can be obtained by relief molding, that is, extrusion, on a suitable surface (in particular, metal). A channel in the form of a helical line can be made on -- the outer side surface of a cylinder inserted into a tube. In addition, such a channel can be made on the inner side surface of an empty cylinder into which a cylindrical element is inserted. Channels of almost any shape can be produced using lithography and plastic or metal molding. - 35 In the table below, as an example, the temporary indicators of pressure equalization are indicated from half to one-tenth of Ge) when the pressure difference between the surrounding space and the gas space with a volume of Zml is less than 20 hPa (20 mbar) for channels of round cross-section, of different lengths and of different diameters. "4 Z s pis nyt ne y" 91164010 85560

F va |v 16111111 nn shi i nik: But i. 813500 tallow salt 16611111 - 70 : . not

Instead of one channel in the device, you can provide several channels of this type, or you can

GC) use a plate made of porous material with open pores, for example, sintered material with open pores. The average diameter of the pores ranges from 0.1 to 150 μm. The volume of pores is from 1 to 40906 of the volume of the element made of sintered material. Plastic, such as polyethylene, polypropylene, polyvinylidene fluoride, or glass, quartz, ceramics, or metal, can be used as an adhesive material for the manufacture of such an element. The thickness of the plate can be from 1 to 5 mm. A round plate is best, which can be hermetically inserted, for example pressed or glued, optimally into a recess in the bottom of the outer vessel. In addition, a permeable membrane in the form of a film, fabric or non-woven material can be used, which has many such channels and is made of a thermoplastic such as polytetrafluoroethylene or polyetheretherketone, or of an elastomer such as silicone or latex.

Permeable membranes in the form of fabric or non-woven material can be made of natural fibers, mineral fibers, glass fiber, carbon fiber, metal fibers, or polymer fibers. In addition, a permeable membrane can be used in the form of a metal foil, such as gold, silicon, nickel, high-quality steel, or in the form of a glass or ceramic film. 65 Channels in such a permeable membrane can be placed in a disordered manner and produced, for example, by ion bombardment or plasma etching. In addition, the channels can be arranged in an orderly manner and obtained, for example, with the help of lithography and molding or by laser stitching, and in this case, the specified large number of channels can be made in a permeable membrane within a narrow field of tolerances on the shape and size of their cross section, as well as on their length.

It is desirable to make the diffusion-impermeable outer vessel from a hard, non-deformable material, for example, from metal. Such an outer vessel makes it easier to store and operate a two-chamber vessel and protects the inner vessel from external mechanical influences.

The device proposed in the invention for equalizing pressure can be used, for example, in a two-chamber vessel intended for storing a medical liquid, which contains, for example, a drug dissolved in 7/0 Appropriate solvent. For example, water, ethanol or their mixtures can be used as a solvent. The drug can be, for example, berotec (fenoterol hydrobromide; 1-(3,5-dihydroxyphenyl)-2-((1-(4-hydroxybenzyl)ethyl|amino|ethanol) hydrobromide), atrovent (ipratropium bromide), berodual (fenoterol hydrobromide in combination with ipratropium bromide), salbutamol (or albuterol), combivent, oxyvent (oxytropium bromide), Va 679 (tiotropium bromide), BEA 2108 (tropene ether of di(2-thienyl)glycolic acid), flunisolide, budesonide etc.

The pressure equalization device proposed in the invention has the following advantages: it has no moving parts and is a static device; there is an opportunity to regulate gas permeability, including when using a permeable membrane or a plate made of sintered material; at any pressure difference, it ensures immediate initiation of pressure equalization; the pressure difference equalizes gradually and smoothly. The time constant, and thereby the duration of pressure equalization when properly used, can be reconciled with the time course of the liquid removal process from the inner vessel; it can be used for diffusion-impermeable outer vessels made of any material, while the outer vessel can be made of a hard (non-deformable) material such as metal or plastic or of a flexible material; i) it excludes accidental access to the gas space between the outer and inner vessels and protects the soft and deformable) inner vessel; after the end of the pressure equalization time, the pressure difference is practically zero; because it enables the creation of a compound with certain parameters between the gas space and the atmospheric air; when the heat-sealed film is removed, it is gas-permeable and ensures the flow of gases in all 787 directions; so it does not need to be applied to it any external actions and no extraneous forces, and it continuously performs its function; it is a substance that is reported from the liquid present in the inner vessel , and penetrates as a result of diffusion through the wall of this inner vessel into the intermediate space between the inner and outer vessels, is reported from this intermediate cavity mainly due to diffusion through at least one channel. As a result of a long period of use of the liquid present in the inner vessel, only an extremely small part of the volatile matter that is reported from the liquid in this inner vessel, while such loss is significantly less than in " Known two-chambered vessels; in c a two-chambered vessel, the inner vessel of which contains a liquid, even with limited diffusion impermeability of this inner vessel can stored for many months without any significant loss of volatile matter and maintain suitability for use for several months; it is cost effective to manufacture and can be made in large quantities,

The pressure equalization device proposed in the invention can be used, for example, in

Ge" two-chamber vessel filled with liquid, which is sprayed, for example, using the aerosol sprayer described in U/O 97/12687.

Sh- Below, the device proposed in the invention is considered in more detail on the example of some variants of its execution with reference to the attached drawings.

Figure 1 shows a longitudinal section of a two-chamber vessel before the first withdrawal of liquid from it. At the same time, a soft deformable (compressed) inner vessel (2), 4) filled with liquid (3) is placed inside the outer vessel (1). A tube (4) intended for its selection is immersed in this liquid. The inner vessel is hermetically connected to the outer vessel by its end (not shown). Between both vessels there is a gas space (5). In the bottom (6) of the outer vessel, a straight channel (7) is made, connecting the gas space (5) with the outer space that surrounds the two-chamber vessel. This channel is closed with a thermally welded film (8)0

In Fig.2, a two-chamber vessel is shown in a longitudinal section after the selection of a part from the inner vessel

F) liquids. At the same time, the thermally welded film (8) is shown partially detached, and the inner vessel ka is shown partially compressed.

Fig. 3 in a longitudinal section shows another version of the two-chamber vessel before the first in the selection of liquid from the inner vessel. At the same time, the direct channel (7) is hermetically closed from the end facing the outer space with a tightly fitting plug (9). Before the first sampling of liquid from the inner vessel, this plug is removed manually by pulling it out by the loop (10).

Figure 4 shows a spiral channel (11), a little more than three turns of which are located on the outside of the bottom (6) of the outer vessel (1). Fig. 5 shows this version in a longitudinal section. At the same time b5, one end of the channel ends in a recess (12), and the other end - in an opening (13). The spiral channel is closed from the outside with a thermally welded film (8), which is pierced with a pointed object or needle (14) before the first liquid withdrawal.

Another version of the two-chamber vessel is shown in Fig. b in a longitudinal section. At the same time, there is a recess in the bottom (6) of the outer vessel, in which there is an insert (15), sealed by an annular seal (17).

Regarding the wall of this depression. A straight channel (7) is made in the insert (15), one end of which ends in a hole (18) in the bottom of the depression. A filter (16) is installed before the other end of the channel (7).

Fig. 7 in a longitudinal section shows the next embodiment of the invention, while the insert (19) is located in a recess sunk inside the outer vessel in its bottom (6). The insert (19) is fixed in the recess with a clip-on connection (20) and sealed against the walls of this recess with a sealing ring (21). 70 The straight channel (23) is located eccentrically with respect to the center of the insert (19). One end of this channel ends in the hole (25) at the bottom of the depression, and the other end ends in the notch made in the insert (19), in which the filter (24) is installed. In the insert (19) there is another notch (26). This recess (26) is connected to the recess for the filter (24) by a groove (22). From the outside, the insert (19) is covered with a thermally welded film (8), which is pierced with a needle (14) before the first liquid (3) is taken from the inner vessel (2). When installing the insert (19) in the recess in the bottom (6) of the vessel, this insert should be placed in a strictly specified orientation so that the hole (25) communicates with the channel (23).

Fig. 8, in longitudinal section, shows another embodiment, in which the insert (27) is also located in a recess sunk inside the outer vessel in its bottom (6). The insert (27) is fixed in the recess with a clip-on connection (20) and is sealed against the walls of this recess with a sealing ring (21).

The straight channel (23) ends in a circular groove (2va; 285) made in the insert (27). The circular groove can have different depths. In Fig. 8, on the site (2va) in the area of the channel (23), it is made less deep than on its other part (285). At the same time, the hole (25) at the bottom of the depression ends in any azimuthal position of the insert (27) in the circular groove (28).

Fig. 9 shows another version of the invention in a longitudinal section. At the same time, a plate (29) made of sintered material is pressed into the sunken vessel inside the outer vessel, deep in its bottom (6). There is a hole (25) in the wall of this recess made at the bottom of the outer vessel. During the storage period, the bottom of i) the outer vessel is closed with a thermally welded film (8), which is pierced or torn off before the first liquid withdrawal from the inner vessel. co

Claims (1)

30 Formula of the invention - what , what , , , . , with 1. A device for equalizing the pressure in a two-chamber vessel consisting of an outer vessel and an inner vessel, and the inner vessel is at least partially filled with a volatile liquid, and the two-chamber vessel itself is placed in the surrounding space filled with gas, while the inner "so vessel ( 2) made partially diffusion-impermeable to at least partially volatile liquid (3) and soft, with the possibility of deformation, while the outer vessel (1) is diffusion-impermeable, rigid (undeformable) and hermetically connected to the inner vessel (2), while between the outer vessel (1) and the inner vessel (2) there is a space (5) for gas, which is connected by at least one channel (7; 11; 23) to the space around the two-chamber vessel, and the cross-sectional area of at least one channel corresponds to its equivalent diameter from 710 to 500 μm, and the length of at least one channel is from five thousand times to one tenth of its equivalent diameter. :z" 2. Device for equalizing pressure according to claim 1, which is characterized by the fact that the length of the channel (7; 11; 23) is from one hundred times to one tenth, in the preferred embodiment, from ten times to one time of its equivalent diameter. FO Z. A device for equalizing pressure according to claim 1 or 2, which differs in that the channel (7; 11; 23) has a round, close to square, triangular or trapezoidal cross-section. - 4. A pressure equalization device according to any of claims 1 - C, which is characterized by the fact that the channel (7; 23) oo is made straight or in the form of a meander, a spiral (11) or a helical line. 5. A device for equalizing pressure according to any of claims 1 - 4, which is characterized by the fact that the channel (7; 11) is made in the wall of the outer vessel or the channel is made in a manufactured insert (15 ; 19; 27), which is placed in the wall of the outer vessel (1) or, optimally, in the recess (12) sunk inside the outer vessel, while the channel is connected to the opening (18; 25) in the wall of the outer vessel (1). 6. A pressure equalization device according to any one of claims 1 - 5, characterized in that the channel (7; 11; 23) has a cross-sectional area of less than 1 mm. (Ф) 7. A pressure equalization device according to any of claims 1 - b, which is characterized by the fact that a gas permeable filter (16; 24) is located at one end of the GI channel (7; 23), optimally at the end facing the surrounding space ). in 8. A device for equalizing pressure according to any of claims 1 - 7, which is characterized by the fact that the end of the channel (7; 11; 23) facing the surrounding space is covered with a film (8) that is welded by thermal welding. 9. A device for equalizing pressure according to claim 1, characterized in that it contains a large number of channels connecting the gas space between the outer vessel and the inner vessel with the space around the two-chamber vessel, the channels being formed by open pores in the plate (29) with sintered material, 65 and the average diameter of the pores is from 0.1 μm to 150 μm with their volume, which is from 195 to 40 95 of the volume of the sintered material plate. 10. The device for equalizing pressure according to claim 1, which is characterized by the fact that it contains a large number of channels, which has a permeable membrane, made in the form of a film, foil, cloth or non-woven material. 11. A device for equalizing pressure according to claims 10, characterized in that the permeable membrane is made of Thermoplastic, such as polytetrafluoroethylene or polyetheretherketone, or when made of an elastomer, such as silicone or latex. 12. The device for equalizing pressure according to claims 10, which is characterized in that the permeable membrane is made in the form of a foil of a metal such as gold, silicon, nickel, high-quality steel or in the form of a film of glass or ceramics, while these channels are arranged randomly or orderly 70 13. A device for equalizing pressure according to claims 9, which is characterized by the fact that a large number of channels are formed with open pores in the plate, which is made of sintered plastic, optimally polyethylene, polypropylene, polyvinylidene fluoride or glass, quartz, ceramics or metal. 14. The device for equalizing pressure according to claim 1, which is characterized by the fact that the outer vessel is made of a solid (non-deformed) material, optimally of metal. 6) (ze) «- (ee) in (Se) - and? (o) - and (ee) - 70 syu» ime) 60 b5